Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-05 @ 6:00 PM
Study NCT ID:
NCT02101567
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2014-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Haemorrhage Following Caesarean Section
Sponsor:
Beni-Suef University
Organization:
Study Overview
Official Title:
A Comparison Between Carbetocin, Oxytocin and Ergometrine in Prevention of Postpartum Haemorrhage Following Caesarean Section
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators compare the effectiveness and adverse effects of I.V carbetocin versus oxytocin \& ergometrine I.V for prevention of postpartum haemorrhage following cesarean section.
Detailed Description:
* Postpartum hemorrhage (PPH) accounts for nearly one quarter of all maternal deaths worldwide 1 and was the second most frequent cause of maternal death in the UK for the 2000-2002 triennium.
* Caesarean section is a recognized risk factor for PPH and the worldwide caesarean delivery rate is increasing .2
* A combination of oxytocin and ergometrine is effective in preventing postpartum hemorrhage but is frequently associated with side effects such as retained placenta and hypertension.
* A recent guideline on PPH prevention developed by the World Health Organization recommended the use of oxytocin for prevention of PPH in settings in which active management of labor is not practiced.
* Ergometrine is an ergot alkaloid and hypertension and cardiac disease are contraindications due to the possible development of severe hypertension and myocardial ischemia.
* Carbetocin is a newly developed uterotonics and it may represent a promising choice as reported in the literature. It is a synthetic analogue of human oxytocin with structural modifications that increase its half-life thereby prolonging its pharmacological effects .
* A prospective double blinded randomized study . The study population will include 200 patients. The study will take place in Beni\_suef University Hospitals.
* Inclusion criteria:
• Women with a singleton pregnancy undergoing elective caesarean section after 37 weeks of gestation.
* Exclusion criteria
* Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
* women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
* Hypertension with pregnancy.
* Cardiac and coronary diseases with pregnancy
* Women included in the study were divided into 2 groups:
.Group (A): including 100 patients who will receive carbetocin 100 µg I.V after delivery of the fetal head.
.Group (B): including 100 patients who will receive a combination of intraoperative oxytocin 5 I.U \& ergometrine 0.2 mg.
* Caesarean section is a recognized risk factor for PPH and the worldwide caesarean delivery rate is increasing .2
* A combination of oxytocin and ergometrine is effective in preventing postpartum hemorrhage but is frequently associated with side effects such as retained placenta and hypertension.
* A recent guideline on PPH prevention developed by the World Health Organization recommended the use of oxytocin for prevention of PPH in settings in which active management of labor is not practiced.
* Ergometrine is an ergot alkaloid and hypertension and cardiac disease are contraindications due to the possible development of severe hypertension and myocardial ischemia.
* Carbetocin is a newly developed uterotonics and it may represent a promising choice as reported in the literature. It is a synthetic analogue of human oxytocin with structural modifications that increase its half-life thereby prolonging its pharmacological effects .
* A prospective double blinded randomized study . The study population will include 200 patients. The study will take place in Beni\_suef University Hospitals.
* Inclusion criteria:
• Women with a singleton pregnancy undergoing elective caesarean section after 37 weeks of gestation.
* Exclusion criteria
* Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
* women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
* Hypertension with pregnancy.
* Cardiac and coronary diseases with pregnancy
* Women included in the study were divided into 2 groups:
.Group (A): including 100 patients who will receive carbetocin 100 µg I.V after delivery of the fetal head.
.Group (B): including 100 patients who will receive a combination of intraoperative oxytocin 5 I.U \& ergometrine 0.2 mg.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: